Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali

This is an interventional prevention trial for Malaria focused on measuring PfSPZ Vaccine, Malaria, Plasmodium falciparum Read More

• INCLUSION CRITERIA:

  1. Age greater than or equal to 18 and less than or equal to 35 years
  2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
  3. In good general health and without clinically significant medical history
  4. Willing to have blood samples stored for future research
  5. Available for the duration of the study

  6. Females of childbearing potential must be willing to use reliable contraception (as defined below) from 21 days prior to Study Day 1 to 28 days after last vaccination.

     • Reliable methods of birth control include:

       • one of the following: confirmed pharmacologic contraceptives (parenteral) delivery; intrauterine or implantable device. OR
       • two of the following: a documented oral or transdermal or vaginal ring contraceptives; PLUS condoms with spermicide or diaphragm with spermicide.
     • Note, Coartem (artemether specifically) may reduce the effectiveness of systemic hormonal contraceptives, therefore additional barrier methods such as condoms must also be used during the 3 days of Coartem dosing.
     • Women who are not able to get pregnant will also be required to report date of last menstrual period, history of surgical sterility (i.e. tubal ligation, hysterectomy) or premature ovarian insufficiency (POI), and will have urine or serum pregnancy test performed per protocol.

EXCLUSION CRITERIA:

1. Pregnancy, as determined by a positive urine or serum human chorionic gonadotropin (beta-hCG) test (if female). NOTE: Pregnancy is also a criterion for discontinuation of any further dosing or non-safety related interventions for that subject.
2. Currently breast-feeding (if female)
3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
4. Hemoglobin (Hb), WBC, absolute neutrophils, and platelets outside the local laboratory- defined limits of normal (subjects may be included at the investigator s discretion for not clinically significant values)
5. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal (subjects may be included at the investigator s discretion for not clinically significant values)
6. Infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B (HBV)
7. Known or documented sickle cell disease by history (Note: known sickle cell trait is NOT exclusionary)
8. Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc.
9. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis
10. History of receiving any investigational product within the past 30 days
11. Participation or planned participation in a clinical trial with an investigational product prior to completion of the follow-up visit 28 days following last vaccination OR planned participation in an investigational vaccine study until the last required protocol visit
12. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
13. History of a severe allergic reaction(Grade 3 or higher or per PI discretion) or anaphylaxis
14. Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)
15. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia
16. Known immunodeficiency syndrome
17. Known asplenia or functional asplenia

18. Use of:

    • Chronic (greater than or equal to 14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of vaccination
    • Use of antimalarials or systemic antibiotics with known antimalarial activity within 5 drug half-lives prior to the first vaccine (such as artemether, artemether-lumefantrine, sulfadoxine-pyrimethamine, trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones or azithromycin)
19. Receipt of a live vaccine within the past four weeks or a killed vaccine within the past two weeks prior to Vaccination #1 and every subsequent vaccination day
20. Receipt of immunoglobulins and/or blood products within the past six months
21. Previous receipt of an investigational malaria vaccine in the last five years
22. Known allergies or other contraindications against Coartem
23. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol